Evaluating Pharmacokinetics and Pharmacodynamics of Jusline

Bioequivalence of Jusline Following Subcutaneous Administration in Healthy Subjects

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00532766

Enrollment

Registered

2007-09-20

Start date

2006-11-30

Completion date

2007-02-28

Last updated

2007-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy subjects

Brief summary

To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline) after subcutaneous administration, and to compare this profile with Humulin insulin.

Detailed description

To study the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline) after subcutaneous administration in the abdominal, and to compare this profile with Humulin insulin for three different preparations (Regular, NPH, and Premixed Regular/NPH (30/70)).

Interventions

DRUGJusline

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy * Non-diabetic * Age 18-35 year * Normal body mass index (BMI 18-25 kg/m2)

Exclusion criteria

* Diabetics * Overweight/obese * Anemic, with liver, cardiac, renal or thyroid dysfunction

Design outcomes

Primary

Measure	Time frame
To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline)	—

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026